Human-Machine System for the H2 Lower Limb Exoskeleton

NCT02114450 | Recruiting

• 2 other identifiers: 14107HSC-MS-14-0129
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

Brief Summary

This research study will investigate the use of smart lower limb robotic exoskeleton (developed by the CSIC, Spain) in rehabilitation after stroke. It will compare robotic-assisted rehabilitation with supervised motor practice. Additionally, it will also examine the use of noninvasive scalp electroencephalography (EEG) to learn specific brain wave patterns associated with learning to walk on the powered lower limb exoskeleton. The findings will be used to understand human-robot interaction and to design smart orthotic devices that can be controlled by thought activity and assist those that have lost all or part of their walking abilities.

Conditions

Stroke; Hemiparesis

Keywords

Stroke; Paresis; Gait rehabilitation; Human-Machine Interaction; Wearable Robotic Devices

Outcome Measures

Primary Outcomes (4)

• Change from baseline in Fugl-Meyer Assessment - Lower Extremity Motor Function

  This test evaluates and measures recovery in post-stroke hemiplegic patients, used in both clinical and research settings and is one of the most widely used quantitative measures of motor impairment. It uses an ordinal scale for scoring of 17 items for the lower limb component and 7 items on the Balance component of the F-M scale (0;con not perform; 1:can perform partially; 2:can perform fully). The total score ranges from 0 to 34, with higher scores representing better function.

  Baseline, Post-Intervention (within a week of completion), Follow-up at 2 weeks, Follow-up at 2 months

• Change from baseline in Functional Gait Assessment

  This scale assesses postural stability during various walking tasks using a 10-item test with each item scored from 0 to 3 (0 = severe impairment and 3 = normal ambulation). This test has high criterion validity to assess functional status in stroke patients, and has been shown to be responsive to measure change.

  Baseline, Post-Intervention (within a week of completion), Follow-up at 2 weeks, Follow-up at 2 months

• Change from baseline in Lower limb joint kinematics during walking

  Lower limb joint kinematics (bilateral hip, knee and ankle joints) will be assessed through surface motion sensors placed on the skin during walking. This assessment will help study and characterize subtle changes in lower limb kinematics pre- and post-intervention.

  Baseline, Post-Intervention (within a week of completion), Follow-up at 2 weeks, Follow-up at 2 months

• Change in cortical dynamics measured by Electroencephalography (EEG)

  Time and frequency domain analysis will be performed on scalp EEG signals to characterize changes in cortical dynamics, specifically in gait initiation and sensory-motor cortical networks. Additionally, we will also evaluate the extent to which lower limb kinematics during gait can be reconstructed from scalp EEG of the user. This will be used to evaluate the neural basis of changes in lower limb joint motion as well as develop EEG-based brain-machine interfaces to robotic exoskeletons.

  Each Experimental/Training Session (12 visits) over the 4 week training period

Secondary Outcomes (4)

• Change in robotic measure of performance measured by the H2

  Each Experimental/Training Session (12 visits) over the 4 week training period

• Change from baseline in Berg Balance Scale score

  Baseline, Post-Intervention (within a week of completion), Follow-up at 2 weeks, Follow-up at 2 months

• Change from baseline in distance walked during the 6-minute walk test

  Baseline, Post-Intervention (within a week of completion), Follow-up at 2 weeks, Follow-up at 2 months

• Change from baseline in Timed Up and Go Test score

  Baseline, Post-Intervention (within a week of completion), Follow-up at 2 weeks, Follow-up at 2 months

Study Arms (2)

Robot-assisted Rehabilitation

EXPERIMENTAL

Participants will receive Robot-assisted training with the H2 lower limb powered exoskeleton. They will perform walking and other lower limb exercises (as applicable) while wearing the H2 lower limb powered exoskeleton. Training will involve 3 sessions per week for 4 weeks, each lasting about 1.5 hours.

Behavioral: Robot-assisted training with the H2 lower limb powered exoskeleton

Supervised motor practice

ACTIVE COMPARATOR

Participants in this group will perform walking and other lower limb exercises (as applicable) under the supervision of a research physical therapist. Training will be for 3 sessions per week for 4 weeks, each session lasting about 1.5 hours.

Behavioral: Supervised motor practice

Interventions

Robot-assisted training with the H2 lower limb powered exoskeleton BEHAVIORAL

The H2 is a powered, robotic lower limb exoskeleton with actuated hips, knees and ankles. A custom control algorithm has been implemented in this device, which allows for provision of assistance to lower limb segments during movement, dependent on user needs.

Robot-assisted Rehabilitation

Supervised motor practice BEHAVIORAL

Supervised motor practice involves lower limb rehabilitation, primarily walking and other applicable lower limb exercises performed by participants under the guidance and supervision of a research physical therapist.

Supervised motor practice

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Sub-acute or chronic stroke i.e., interval of at least 3 months or interval of at least 6 months from stroke to time of enrollment, respectively;
• Cognitive ability to assimilate and participate actively in the treatment protocol (Mini Mental State Examination score \> 24 points, out of a total 30 indicating normal cognitive ability);
• Modified Rankin scale scores 2-4 (Mild-Moderate functional disability post-stroke);
• Modified Ashworth Scale of Spasticity score \<= 2 (ranges from 0-4 with 4 reflecting maximum spasticity);
• Have no skin integrity issues;
• Sufficient passive range of motion at the hip (at least 90 deg flexion, 15-20 deg extension), knee (90 deg flexion, complete extension) and ankle (15 deg dorsiflexion, 15 deg plantarflexion);
• Have no contraindications to standing or walking; able to stand with assistive device for at least 5 minutes, and able to walk with assistive device for 10 m.

You may not qualify if:

• Severe cognitive and/or visual deficit;
• Hemineglect (determined based on medical record or initial clinical assessment);
• Severe sensory deficit;
• Joint contractures of any extremity that limits normal range of motion during ambulation with assistive devices;
• Skin lesions that may hinder or prevent the application of exoskeleton;
• Uncontrolled angina;
• Severe chronic obstructive pulmonary disease;
• Other medical contraindications; any medical co-morbidities that would prevent standard rehabilitation.
• Able to understand and sign the consent form
• Age 18-75 years
• \- History of neurological, neuromuscular or physical disability.

Sponsors & Collaborators

• University of Houston: lead
• The University of Texas Health Science Center, Houston: collaborator
• TIRR Memorial Hermann: collaborator

Study Sites (2)

TIRR Memorial Hermann Hospital

Houston, Texas, 77056, United States

NOT YET RECRUITING

University of Houston

Houston, Texas, 77204, United States

RECRUITING

Related Publications (3)

• Bortole M, Venkatakrishnan A, Zhu F, Moreno JC, Francisco GE, Pons JL, Contreras-Vidal JL. The H2 robotic exoskeleton for gait rehabilitation after stroke: early findings from a clinical study. J Neuroeng Rehabil. 2015 Jun 17;12:54. doi: 10.1186/s12984-015-0048-y.

  PMID: 26076696 BACKGROUND

• Contreras-Vidal JL, Bortole M, Zhu F, Nathan K, Venkatakrishnan A, Francisco GE, Soto R, Pons JL. Neural Decoding of Robot-Assisted Gait During Rehabilitation After Stroke. Am J Phys Med Rehabil. 2018 Aug;97(8):541-550. doi: 10.1097/PHM.0000000000000914.

  PMID: 29481376 BACKGROUND

• M. Bortole and J.L. Pons, "Development of a Exoskeleton for Lower Limb Rehabilitation," in Converging Clinical and Engineering Research on Neurorehabilitation Biosystems & Biorobotics vol. 1, no. 14, Berlin, Heidelberg: Springer Berlin Heidelberg, 2013, pp. 85-90

  BACKGROUND

Related Links

• University of Houston Brain-Machine Interface System Team (Dr.Contreras-Vidal, UH)
• The UTHealth Center for Wearable Exoskeletons at TIRR Memorial Hermann Hospital (Dr.Francisco, UTHealth)

MeSH Terms

Conditions

Stroke; Paresis

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jose L Contreras-Vidal, PhD

  University of Houston

  PRINCIPAL INVESTIGATOR

• Gerard E Francisco, MD

  TIRR Memorial Hermann Hospital

  PRINCIPAL INVESTIGATOR

• Jose L Pons, PhD

  Spanish Research Council

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jose L Contreras-Vidal, PhD

CONTACT

713-743-4429; jlcontreras-vidal@UH.EDU

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Hugh Roy and Lillie Cranz Cullen University Professor

Study Record Dates

• First Submitted: April 8, 2014
• First Posted: April 15, 2014
• Study Start: November 20, 2015
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2029
• Last Updated: October 30, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)